Tag Archives: chemical substance

ECHA Modifies REACH Tonnage Calculations

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In REACH news, the European Chemicals Agency (ECHA) has modified its methodology for calculating “total tonnage” bands. Make a note of it if you haven’t already.

The shortcomings in the legacy calculation methodology, ECHA is saying, arose from the fact that the REACH Regulation is based on the concept of legal entities rather than companies. To make a long story short, in some situations the old way could lead to involuntary disclosure of confidential business information.

So the agency has decided to modify the envisaged methodology for calculating aggregated tonnages.

The modification removes the “four registrants rule” before publication of tonnage band data on the ECHA website. As it was, the tonnage data— claimed confidential by a given registrant— would still be included in the calculation of aggregated tonnages if there are four or more registrants in a joint submission. This would threaten the Confidential status.

Tonnage amendment already in place  The publication of tonnage bands on ECHA’s registered substances database that took place for the first time in June.  Repeat: ECHA already took the modifications in the calculation method into account.

The “total tonnage band” is published together with other substance-specific information on ECHA’s website.

Total tonnage bands will be displayed for substances on ECHA’s registered substances database from those listed in the following table:

Table source: courtesy ECHA

 

Tonnage data will be extracted from the latest disseminated dossier of each full (non-intermediate) registration, aggregated, converted to a total tonnage band, and published on ECHA’s registered substances database. The total tonnage bands will be published for joint submissions and for inpidual submissions. Tonnage data will not be extracted from dossiers for intermediate registrations under REACH Articles 17 or 18. Tonnage data will also not be extracted from dossiers for full (non-intermediate) registrations where the tonnage band is claimed to be confidential in accordance with REACH Article 119(2)(b).

Claiming confidential Registrants have had the facility to claim their tonnage band confidential in accordance with REACH Article 119(2)(b) since June 2008. If registrants have not done so but wish to claim confidentiality for their tonnage band, they should submit an updated dossier with a confidentiality claim on the tonnage band as soon as possible.

For confidentiality claims under REACH, please note that the claim must be justified in accordance with Data Submission Manual 16, and will attract a fee. Confidentiality will only be granted where the claim is accepted as valid by ECHA. Notably, tonnage data will not be extracted from dossiers where the tonnage band is claimed confidential while the confidentiality claim is under assessment.

Reviving TSCA: Safe Chemicals Act Revision 2011

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On April 14, Sen. Frank Lautenberg (D-NJ) proposed “The Safe Chemicals Act, Version 2” to Congress.  Reception is lukewarm and the legislation is not expected to pass.  However, all industry persons should be familiar with the basics of the proposal.

SCA 2011 E-Z: articles, mixtures and nanos. In common language, SCA 2011 differs from SCA 2010 in three key ways.

In terms of articles, the new revision would not specifically amend the definition of chemical substance to include chemicals in articles.  “Articles” typically means “finished goods,” like a table, chair, electronic device or other saleable manufactured item for the market.  Under SCA 2011, chemical substances imported as part of an article would be subject to the same requirements as if they had been imported in bulk, with some exceptions.

Mixtures are again a hot topic:  current TSCA allows testing and reporting rules and control actions to be issued for mixtures, although EPA rarely implements related procedures.  SCA 2011 unloads many of last year’s mixture requirements so that it more closely resembles the current TSCA status quo.  SCA 2011 would let EPA take actions relating to mixtures in the same manner as actions relating to chemical substances — in the event that EPA determined that doing so would be reasonable and efficient.

In the realm of nanomaterials, SCA 2011 is similar to SCA 2010 in that it lets EPA determine whether nanoscale versions of existing macroscale chemicals are new chemicals.

SCA 2011 E-Z: in context. The esteemed Washington, DC, environmental law in Beveridge and Diamond aptly commented on the upshot of SCA 2011 by pointing out, “With the Republican majority in the House of Representatives unlikely to consider TSCA legislation this Congress, passage of SCA 2011 is unlikely. Nevertheless, SCA 2011 will probably stimulate efforts by stakeholders to educate Congress and each other on a variety of approaches to overhauling TSCA that can address the deficiencies in the current statute while obtaining sufficient support to be enacted.”

The SCA 2011 aims to endow EPA with sufficient information to judge a chemical’s safety.  It requires manufacturers to develop and submit a minimum data set for each chemical they produce, while also preventing duplicative or unnecessary testing and encouraging the use of rapid, low-cost, non-animal tests that provide high quality data.  Again, the onus of chemical evaluation and disclosure is intended to fall on chemical manufacturers, not manufacturers in general.

The American Chemistry Council (ACC) and its members have announced they support efforts by the US Congress to modernize chemical management. A modern system, says the ACC, should place protecting the public health as its highest priority, and should include strict government oversight.

 

5 Case Studies on REACH Compliance

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For companies still wondering how their situation fits into REACH, the following case studies may help. These case studies address compliance in a variety of scenarios. The five instances of how-other-companies-did-it represent common situations. The case studies address both upstream and downstream scenarios.

1. Downstream user under REACH (with confidential uses)
A medium sized company supplying preparations to the marine sector consider implications of keeping this use of a substance confidential from their suppliers; find out what further action they may need to follow as a downstream user under REACH.

2. Global manufacturing company seeks to automate the collection of supplier data for REACH
A Fortune 500 manufacturer and retailer with operations worldwide seeks to automate supplier chemical data collection as much as possible for compliance with REACH.

3. AstraZeneca, a pharmaceutical manufacturer, and famous furniture company Herman Miller along with an automobile agency voice software testimonials on software products they use to manage substance-level compliance with substances under REACH and similar regulations.

4. An alloy producer (see also RoHS) clarifies duties under REACH
A producer of alloys determines that under REACH it is the component metals that constitute the alloys they manufacture that are within the scope of registration and for one of these that they import they will have registration obligations.

5. REACH and a company importing a solvent from the US
A company importing a solvent for the first time from outside the EU is concerned about having missed the preregistration deadline but finds they can pre-register and get help from other SIEF members.

These case studies — unless otherwise indicated and linked above — may be found on the web (at the time of this posting) at the following URL:  hse.gov.uk/reach/casestudies/index.htm.